Hepatocellular CarcinomaPhase 3NCT06089369
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion
A Phase 3 study testing Sintilimab (9 cycles), Sintilimab (18 cycles) and Active surveillance in people with Hepatocellular Carcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sintilimab (9 cycles), Sintilimab (18 cycles) and Active surveillance
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a histopathological diagnosis of HCC
- Undergone a curative resection
- Pathologically confirmed HCC with microvascular invasion (MVI)
- Aged 18-75 years
- No previous systematic treatment and locoregional therapy for HCC prior to randomization
- Absence of major macrovascular invasion
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- No extrahepatic spread
- Full recovery from Curative resection within 4 weeks prior to randomization
- Child-Pugh: Grade A or B(7)
- ECOG-PS score: 0 or 1
- Subjects with HCV- RNA (+) must receive antiviral therapy
- Adequate organ function
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
- Any preoperative treatment for HCC including local and systemic therapy
- Have received more than 1 cycle of adjuvant TACE following surgical resection
- Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
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- Cardiac clinical symptom or cardiovascular disease that is not well controlled
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Inability or refusal to comply with the treatment and monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.
Read the detailed description
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab (9 cycles), Sintilimab (18 cycles), Active surveillance
- Keywords
- Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab (9 cycles)Drug
Also called IBI 308
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles）
Sintilimab (18 cycles)Drug
Also called IBI 308
IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles）
Active surveillanceOther
Active surveillance
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab for six months group (9 cycles) | Experimental | Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred. Receives: Drug: Sintilimab (9 cycles) |
| Sintilimab for one year group (18 cycles) | Experimental | Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred. Receives: Drug: Sintilimab (18 cycles) |
| Active surveillance | Active comparator | Patients are closely monitored postoperatively. Receives: Other: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS)
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Measured: Randomization up to 60 months
Secondary outcomes (4)
RFS Rate at 12 ,24 , 36 , 60 Months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Measured: Randomization up to 60 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Measured: Randomization up to 60 months
Adverse events
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: Baseline up to 60 months
Quality of Life (QoL) Scale Score
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Measured: Baseline up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089369
- Sponsor's protocol ID
- Adjuvant-01
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study
- ClinicalTrials.gov ID
- NCT06089369
- Acronym / sponsor ID
- Adjuvant-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Programmed Cell Death 1, Checkpoint Inhibitor, Immunotherapy, Adjuvant, Hepatocellular Carcinoma, Microvascular Invasion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.
Detailed description
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sintilimab for six months group (9 cycles) | Experimental | Drug: Sintilimab (9 cycles)Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 9 cycles or until disease recurrence or intolerable adverse effects occurred. |
| Sintilimab for one year group (18 cycles) | Experimental | Drug: Sintilimab (18 cycles)Patients receive Sintilimab at a dose of 200 mg via intravenous injection, with one cycle every three weeks, for a total of 18 cycles or until disease recurrence or intolerable adverse effects occurred. |
| Active surveillance | Active comparator | Other: Active surveillancePatients are closely monitored postoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with a histopathological diagnosis of HCC
- Undergone a curative resection
- Pathologically confirmed HCC with microvascular invasion (MVI)
- Aged 18-75 years
- No previous systematic treatment and locoregional therapy for HCC prior to randomization
Key exclusion criteria (11 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
- Any preoperative treatment for HCC including local and systemic therapy
- Have received more than 1 cycle of adjuvant TACE following surgical resection
- Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sintilimab (9 cycles)Also: IBI 308IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 9 cycles） | Drug | Sintilimab for six months group (9 cycles) |
| Sintilimab (18 cycles)Also: IBI 308IV infusion of Sintilimab （200mg intravenously every 3 weeks for a total of 18 cycles） | Drug | Sintilimab for one year group (18 cycles) |
| Active surveillanceActive surveillance | Other | Active surveillance |
Primary outcome
Recurrence-Free Survival (RFS)
Time frame: Randomization up to 60 months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
4 secondary outcomes
RFS Rate at 12 ,24 , 36 , 60 Months
Time frame: Randomization up to 60 months
Overall Survival (OS)
Time frame: Randomization up to 60 months
Adverse events
Time frame: Baseline up to 60 months
Quality of Life (QoL) Scale Score
Time frame: Baseline up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sintilimab (9 cycles), Sintilimab (18 cycles) and Active surveillance in people with Hepatocellular Carcinoma, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Chen, Prodessor (02783665213, chenxpchenxp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free Survival (RFS) (time frame: Randomization up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.